New Frontiers in Contraceptive Research A Blueprint for Action (2004) / Chapter Skim
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5 Capitalizing on Recent Scientific Advances
5 Capitalizing on Recent Scientific Advances
Pages 134-162
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From page 134... ...
ELEMENTS REQUIRED FOR PROGRESS IN CONTRACEPTIVE RESEARCH AND DEVELOPMENT The blueprint for contraceptive research and product development outlined in this report can be realized only if several key elements are in place, including financial resources wisely deployed, human capital, a research environment that encompasses multiple disciplines relevant to contraception, a framework for increasing effective collaboration among the interested parties in the public and private sectors both in the United 134
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From page 135... ...
The levels of investment by the pharmaceutical industry vary, and the amounts invested by the various companies are generally not disclosed. However, the number of pharmaceutical and biotechnology companies that have invested programs in contraceptive development is modest.
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From page 136... ...
Note that the increased budgets for fiscal years 2001 and 2002 also include significant increases in reproductive health research in addition to contraceptive research, and that other NIH institutes also support some contraceptive research activities. SOURCE: Contraception and Reproductive Health Branch, 2004.
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From page 137... ...
The benefits of improving contraceptive methods and accessibility of contraception have been well documented (see Chapter 1~. The facts about reduced morbidity and mortality and the benefits of positioning families and women physically, socially, and economically to embark on future pregnancies are, in the committee's opinion, more compelling than the rhetoric that has frequently surrounded debate regarding the commitment of federal dollars to family planning-related activities.
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From page 138... ...
Contraceptive research transcends this linear array, requiring a constant interaction among the disciplines to ensure that the end product is both effective and acceptable. While all of these elements may be important for the development of many therapeutic agents, the feedback loops for contraceptive development are far more complex.
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From page 139... ...
CAPITALIZING ON RECENT SCIENTIFIC ADVANCES Step: Target identification and validation Identification of lead compounds Clinical tests for safety in humans Clinical tests for efficacy in humans, Pharmacokinetic evaluation | Introduction to the | market Post-market surveillance Examples of BASIC RESEARCH I methods used: FDA REVIEW AND APPROVAL ADOPTION 139 · Functional Genomics · Proteomics · Lipidomics · Glycomics · Chemical library screens · Lead optimization · Pharmacokinetic studies · Toxicology tests · Efficacy studies in animals Phase I Trials Phase 11, 111 Trials · Provider education · Public education Surveillance for side effects and efficacy discontinuation FIGURE 5.2 The spectrum of biomedical research displayed as a linear process from earliest discovery to clinical application.
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From page 140... ...
The Alliance for Microbicide Development,2 established in 1998, acts as a clearinghouse for all new information on microbicides and keeps an up-to-date database showing the progress of all current lead compounds through the research and development pipeline. One level of the database is open to all and contains only information that is in the public domain or that is not proprietary.
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From page 141... ...
Whether this was a result of a lack of scientific interest, a lack of funding, or a lack of knowledge about the advances and needs in the field is not clear. On an international level, regular meetings dealing with reproductive health already occur.
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From page 142... ...
Examples of this type of body include the Recombinant DNA Advisory Committee (Recombinant DNA Advisory Committee, 2000) , but no similar body exists in the field of contraceptive development.
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From page 143... ...
This situation may be a reflection of the perceived lack of importance of the problem, the applied nature of contraceptive development research, the long time frame needed to bring the work to completion, and the meager funding available. A major challenge is to identify, attract, train, and support the career development of individuals who have an appreciation for the multidisciplinary issues surrounding fertility regulation.
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From page 144... ...
The academic community itself must also appreciate the unique features of contraceptive development research so that those who pursue activities that may be viewed as being outside the traditional path (i.e., applied research or team-based research) are not penalized.
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From page 145... ...
. In contrast, in the early 1980s, the Royal College of Obstetricians and Gynaecologists of the United Kingdom developed subspecializations in
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From page 146... ...
This program differs from the one in the United Kingdom in that it does not grant any official i°Royal College of Obstetricians and Gynaecologists Faculty of Family Planning and Reproductive Health Syllabus for Subspecialisation in Sexual and Reproductive Health: SRH.1 Syllabus. The Faculty of Family Planning & Reproductive Health Care, May 2003.
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From page 147... ...
The multidisciplinary nature of contraceptive development research requires a team approach, as opposed to the traditional investigatorinitiated research approach prevalent in U.S. academic institutions.
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From page 148... ...
,~3 which had limited funds to foster these interactions but which will soon cease.~4 Other international research programs include the Fogarty International Research Collaboration Awards (Fogarty International Center/National Institute of Environmental Health Sciences, 2002) ,~5 which target interactions between a funded U.S.
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From page 149... ...
Collaboration can potentially be hindered by competition among the various organizations in a particular research field, so it would be worthwhile to identify and support mechanisms that would facilitate and increase opportunities for such collaboration in contraceptive research both within the public sector and between public and private entities. These might include meetings focused on contraceptive approaches or on stages of method development sponsored by impartial groups such as NIH, IOM, WHO, the Population Council, CONRAD, and CICCR; funding for the early involvement of experts from fields that will be needed during method development; or funders' encouragement of crosscollaboration.
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From page 150... ...
However, a productive relationship between industry and the public sector is essential for success in translating basic research findings to the clinical setting (Schwartz and Vilquin, 2003~. In the 1996 IOM report on contraceptive research and development, the committee commented that with a few notable exceptions, industry, broadly defined, has not found the potential rewards from the development of new contraceptive methods to be persuasive, given the greater chance of success and higher financial rewards in other areas of therapeutic intervention such as oncology.
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From page 151... ...
Additional funding specifically earmarked for the development of vaginal preparations to prevent HIV infection and other STIs permitted the establishment of a sister project, the Global Microbicide Project (Global Microbicide Project, 2000~. Progress toward the stated objectives of CICCR has been assessed by external review committees of the program as a whole as well as the individual program areas and is documented in the CICCR-Global Microbicide Project 2001-2002 Biennial Report, Addressing Reproductive Health Needs (CICCR (Consortium for Industrial Collaboration in Contraceptive Research)
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From page 152... ...
Oversight of clinical trials, data management and analysis, formulation development, registration, manufacturing, packaging, warehousing and distribution, market introduction, quality assurance, accounting, and sales of Plan B were all accomplished using a virtual organization staffed by three persons. Thus, a large bricks and mortar institution is not essential for all stages of product develop
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From page 153... ...
The committee concludes that PPPs are an effective mechanism to advance research in reproductive health and contraception and that such initiatives have high payoffs for sponsors that invest in them. Combining the complementary strengths of the not-for-profit and for-profit sectors facilitates progress in the translation of lead compounds into products.
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From page 154... ...
, and Gossypol was first tested as a male contraceptive in China in the 1970s (National Co-ordinating Group for Male Contraceptives, 1978~. Many countries, such as Brazil, Chile, China, India, and Mexico, also have flourishing pharmaceutical industries that make reproductive health products, some of which can already produce drugs of Good Manufacturing Practice quality.
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From page 155... ...
However, funding will be required not only for institution building but also for ensuring that clinical trial sites meet Good Clinical Practice standards. For many years WHO has had an institution-building component in reproductive health, including contraceptive research, and has sponsored many multicenter clinical trials of contraceptives in a variety of developing countries.
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From page 156... ...
, PHI, Program for Appropriate Technology in Health, the Population Council, and WHO, have very active programs that involve collaboration with institutions worldwide not just for clinical trials but also for preclinical activities and feasibility and proof-of-concept studies. Improving Dialogue with Regulatory Bodies Contraceptive development requires a regulatory process that is dynamic, meaning that it keeps abreast of changing science, changing needs, and changing opportunities for product development.
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From page 157... ...
These could include exchanges of laboratory techniques as well as ethical approaches for conducting the clinical trials necessary for the review and approval of new contraceptives. RECOMMENDATIONS The blueprint for contraceptive research and product development outlined in this report can be realized only if several key elements are in place, including financial resources and a system to judiciously deploy them, human capital, a research environment that encompasses multiple disciplines relevant to contraception, a framework for increasing effective collaboration among the interested parties in the public and private sectors both in the United States and abroad, and a regulatory environment conducive to contraceptive development.
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From page 158... ...
Recommendation 12: Establish, support, and recognize new programs for training and career advancement in contraceptive research and clinical practice. A cadre of scientists and physicians dedicated to contraceptive development is needed to implement the contraceptive research agenda.
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From page 159... ...
The academic community itself must also appreciate the unique features of contraceptive development research so that those who pursue activities that may be viewed as being outside the traditional path (i.e., applied research or team-based research) are not penalized.
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From page 160... ...
1993. Latin America's contributions to contraceptive development.
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From page 161... ...
1997. Fertility regulation in nursing women: contraceptive performance, duration of lactation, infant growth, and bleeding patterns during use of progesterone vaginal rings, progestin-only pills, Norplant implants, and Copper T 380-A intrauterine devices.
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From page 162... ...
. World Health Organization, Department of Reproductive Health and Research.
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